Bioconnect is committed to meeting or exceeding these demanding quality standards to assure that all requirements for your custom application and those for all standard Bioconnect products are met.

  • FDA Registered Facility
  • FDA Establishment Registrations and Device listing (2032351)
  • FDA 510K Registration (K010809)
  • FDA cGMP Compliant
  • California FDA
  • ANSI/AAMI EC-53-1995 Cable and Lead Standards
  • AAMI (EC-13, EC-53, EC-38)
  • Quality Assurance and Inspection certified to MIL-I-45208
  • Calibration Standards traceable to NIST
  • IPC/EIA J-STD-001 and IPC/WHMA-A-620 Standards
  • IEC 601 Standards
  • DIN 42-802 Standards
  • Internal company quality workmanship standards
  • All products are latex-free and surface materials chosen for biocompatibility